Trial Outcomes & Findings for GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN) (NCT NCT00766493)
NCT ID: NCT00766493
Last Updated: 2016-09-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
30 days
Results posted on
2016-09-29
Participant Flow
This study will be conducted at a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices) and will enroll approximately 250 subjects.
Participant milestones
| Measure |
EMBOLDEN
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Pre-Discharge
STARTED
|
250
|
|
Pre-Discharge
COMPLETED
|
250
|
|
Pre-Discharge
NOT COMPLETED
|
0
|
|
30 Days Post-Procedure
STARTED
|
250
|
|
30 Days Post-Procedure
COMPLETED
|
238
|
|
30 Days Post-Procedure
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
EMBOLDEN
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
30 Days Post-Procedure
Discontinued
|
7
|
|
30 Days Post-Procedure
Missed Visit - Phone Contact f/u
|
4
|
|
30 Days Post-Procedure
Missed Visit - No Phone Contact
|
1
|
Baseline Characteristics
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Baseline characteristics by cohort
| Measure |
EMBOLDEN
n=250 Participants
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
206 Participants
n=99 Participants
|
|
Age, Continuous
|
74.7 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=99 Participants
|
|
History of Diabetes
Yes
|
87 Participants
n=99 Participants
|
|
History of Diabetes
No
|
163 Participants
n=99 Participants
|
|
History of Hypertension
Yes
|
236 Participants
n=99 Participants
|
|
History of Hypertension
No
|
14 Participants
n=99 Participants
|
|
History of Ischemic Stroke
None
|
200 Participants
n=99 Participants
|
|
History of Ischemic Stroke
One
|
34 Participants
n=99 Participants
|
|
History of Ischemic Stroke
Two or More
|
12 Participants
n=99 Participants
|
|
History of Ischemic Stroke
Unknown
|
4 Participants
n=99 Participants
|
|
Previous Endarterectomy
None
|
171 Participants
n=99 Participants
|
|
Previous Endarterectomy
Less than 1 Year
|
13 Participants
n=99 Participants
|
|
Previous Endarterectomy
1 Year or Greater
|
63 Participants
n=99 Participants
|
|
Previous Endarterectomy
Unknown
|
3 Participants
n=99 Participants
|
|
Symptomatology
Symptomatic
|
37 Participants
n=99 Participants
|
|
Symptomatology
Asymptomatic
|
213 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: EMBOLDEN subjects evaluable for the primary endpoint
Outcome measures
| Measure |
EMBOLDEN
n=234 Participants
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Minor Stroke (Overall)
|
6 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Subjects With One or More Major Adverse Events
|
10 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Death
|
2 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Myocardial Infarction (MI - Overall)
|
1 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Q-Wave MI
|
0 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Non-Q-Wave MI
|
1 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Stroke (Overall)
|
7 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Major Stroke (Overall)
|
1 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Ischemic Stroke (Major)
|
1 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Hemorrhagic Stroke (Major)
|
0 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Ischemic Stroke (Minor)
|
6 Participants
|
|
Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure
Hemorrhagic Stroke (Minor)
|
0 Participants
|
SECONDARY outcome
Timeframe: Post ProcedureDevice Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).
Outcome measures
| Measure |
EMBOLDEN
n=250 Participants
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Device Success
|
241 Participants
|
SECONDARY outcome
Timeframe: 30 daysClinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.
Outcome measures
| Measure |
EMBOLDEN
n=250 Participants
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Clinical Success
|
233 Participants
|
SECONDARY outcome
Timeframe: 30 daysAccess Site Complications defined as the presence of a large hematoma (\>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.
Outcome measures
| Measure |
EMBOLDEN
n=250 Participants
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Access Site Complications
|
6 Participants
|
SECONDARY outcome
Timeframe: 30 daysNeurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).
Outcome measures
| Measure |
EMBOLDEN
n=250 Participants
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Neurologic Events
|
16 Participants
|
Adverse Events
EMBOLDEN
Serious events: 56 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EMBOLDEN
n=250 participants at risk
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
6/250 • Number of events 6 • 30 days
|
|
Blood and lymphatic system disorders
Blood & Lymphatic System - Other
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Cardiac disorders
Bradycardia
|
2.0%
5/250 • Number of events 5 • 30 days
|
|
Cardiac disorders
Angina/coronary ischemia
|
1.2%
3/250 • Number of events 3 • 30 days
|
|
Cardiac disorders
Asystole
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Cardiac disorders
Cardiac - Other
|
1.2%
3/250 • Number of events 3 • 30 days
|
|
Cardiac disorders
Congestive Heart Failure (CHF) - onset or worsening of
|
1.2%
3/250 • Number of events 4 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Cardiac disorders
Myocardial infarction (MI)
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Surgical and medical procedures
Thrombosis/Occlusion - GEF
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Retroperitoneal bleed
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
General disorders
Fever
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Infections and infestations
Bronchitis
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Infections and infestations
Infection
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
Groin Hematoma
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.2%
3/250 • Number of events 3 • 30 days
|
|
Injury, poisoning and procedural complications
Infection at access site
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Metabolism & Nutrition - Other
|
0.40%
1/250 • Number of events 2 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue - Other
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Nervous system disorders
Nervous System - Other
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Nervous system disorders
Headache
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Nervous system disorders
Cerebral ischemia/transient ischemic attack (TIA)
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Nervous system disorders
Visual disturbance
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Nervous system disorders
Stroke/cerebrovascular accident (CVA)
|
1.2%
3/250 • Number of events 3 • 30 days
|
|
Nervous system disorders
Seizure
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Nervous system disorders
Ischemic stroke
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Renal failure/insufficiency
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Renal & Urinary - Other
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic & Mediastinal - Other
|
1.6%
4/250 • Number of events 4 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD, worsening of
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Vascular disorders
Hypotension
|
5.6%
14/250 • Number of events 14 • 30 days
|
|
Vascular disorders
Hypertension
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Vascular disorders
Bleeding
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Vascular disorders
Vessel spasm
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Vascular disorders
Vascular - Other
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Vascular disorders
Ischemia/Infarction of tissue/organ
|
0.80%
2/250 • Number of events 2 • 30 days
|
|
Vascular disorders
Pseudoaneurysm
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
Vascular disorders
Vessel dissection, perforation or rupture
|
0.40%
1/250 • Number of events 1 • 30 days
|
|
General disorders
Not Elsewhere Classified - Other
|
0.80%
2/250 • Number of events 2 • 30 days
|
Other adverse events
| Measure |
EMBOLDEN
n=250 participants at risk
GORE® Embolic Filter with carotid artery stenting
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
14/250 • Number of events 14 • 30 days
|
|
Cardiac disorders
Bradycardia
|
4.0%
10/250 • Number of events 10 • 30 days
|
|
Gastrointestinal disorders
Nausea
|
4.8%
12/250 • Number of events 12 • 30 days
|
|
Nervous system disorders
Nervous System - Other
|
5.6%
14/250 • Number of events 15 • 30 days
|
|
Nervous system disorders
Headache
|
4.4%
11/250 • Number of events 11 • 30 days
|
|
Vascular disorders
Hypotension
|
15.2%
38/250 • Number of events 39 • 30 days
|
|
Vascular disorders
Hypertension
|
6.4%
16/250 • Number of events 16 • 30 days
|
|
Vascular disorders
Bleeding
|
4.4%
11/250 • Number of events 11 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER